MedWatch - September 2003 Safety-Related Drug Labeling Changes

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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2003

The detailed view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. The prescribing information may be accessed by clicking on the drug name.

Summary View

Brand (Generic) Name	Sections Modified	Summary of Changes to Contraindications and Warnings
Altocor (lovastatin) Extended-Release Tablets (click product name to read prescribing information)	WARNINGS Myopathy/Rhabdomyolysis Potent Inhibitors of CYP3A4 Lipid-Lowering Drugs That Can Cause Myopathy When Given Alone Other Drugs Liver Dysfuction Lovastatin Immediate-Release PRECAUTIONS Drug Interactions CYP3A4 Interactions Interactions With Lipid-Lowering Drugs That Can Cause Myopathy When Given Alone Other Drug Interactions Amiodarone or Verapamil ADVERSE REACTIONS Hypersensitivity Reactions Dermatomyositis	Myopathy/Rhabdomyolysis Lovastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above 10X the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by high levels of HMG-CoA reductase inhibitory activity in plasma. The risk of myopathy/rhabdomyolysis is increased by concomitant use of lovastatin with the following ... (note: see prescribing information for listing) The risk of myopathy/rhabdomyolysis is dose related. Liver Dysfunction: Lovastatin Immediate-Release It is recommended that liver function tests be performed before the initiation of treatment, at 6 and 12 weeks after initiation of therapy or elevation of dose, and periodically thereafter (e.g., semiannually).

AndroGel (testosterone gel) (click product name to read prescribing information)	WARNINGS PRECAUTIONS Advise Patients of the Following PATIENT PACKAGE INSERT How should I use AndroGel? What should I avoid while using AndroGel?	GELS ARE FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING USE.

Peganone (ethotoin) Tablets (click product name to read prescribing information)	WARNINGS PRECAUTIONS Pregnancy: Pregnancy Category D Nonteratogenic Effects ADVERSE REACTIONS Stevens-Johnson Syndrome	REPORTS HAVE SUGGESTED THAT THE MATERNAL INGESTION OF ANTIEPILEPTIC DRUGS, PARTICULARLY BARBITURATES, IS ASSOCIATED WITH A NEONATAL COAGULATION DEFECT THAT MAY CAUSE BLEEDING DURING THE EARLY (USUALLY WITHIN 24 HOURS OF BIRTH) NEONATAL PERIOD.

Risperdal (risperidone) Tablets and Oral Solution Risperdal M-TAB (risperidone) Orally Disintegrating Tablets (click product name to read prescribing information)	WARNINGS Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients With Dementia	Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients (mean age 85 years; range 73-97) in trials of risperidone in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo. Risperdal is not approved for the treatment of patients with dementia-related psychosis.

Sporanox (itraconazole) Oral Solution (click product name to read prescribing information)	WARNINGS Cystic Fibrosis	If a patient with cystic fibrosis does not respond to Sporanox Oral Solution, consideration should be given to switching to alternative therapy.

Zocor (simvastatin) Tablets (click product name to read prescribing information)	WARNINGS Myopathy/Rhabdomyolysis Other Drugs Gemfibrozil particularly with higher doses of simvastatin Other lipid-lowering drugs (other fibrates or > 1 g/day of niacin) that can cause myopathy when given alone PRECAUTIONS Drug Interactions Interactions with lipid-lowering drugs that can cause myopathy when given alone ADVERSE REACTIONS Concomitant Lipid-Lowering Therapy	Myopathy/Rhabdomyolysis: The dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant medication with gemfibrozil. Caution should be used when prescribing other lipid-lowering drugs (other fibrates or lipid-lowering doses (> 1g/ day) of niacin) with simvastatin, as these agents can cause myopathy when given alone. The dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant medication with cyclosporine.

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Brand (Generic) Name	Sections Modified
Caverject (alprostadil) Sterile Powder Caverject Injection (alprostadil injection) Aqueous Caverject Impulse (alprostadil for injection) Please contact Pfizer at 1-800-879-3477 for prescribing information.	PRECAUTIONS Geriatric Use

Coreg (carvedilol) Tablets (click product name to read prescribing information)	PRECAUTIONS Geriatric Use ADVERSE REACTIONS Congestive Heart Failure Left Ventricular Dysfunction Following Myocardial Infarction Hypertension Laboratory Abnormalities Postmarketing Experience Aplastic Anemia

Fosamax (alendronate sodium) Tablets and Oral Solution (click product name to read prescribing information)	PRECAUTIONS General ADVERSE REACTIONS Postmarketing Experience Body as a Whole Symptomatic Hypocalcemia Skin Stevens-Johnson Syndrome Toxic Epidermal Necrolysis

Ganite (gallium nitrate injection) (click product name to read prescribing information)	PRECAUTIONS Drug Interactions ADVERSE REACTIONS Miscellaneous

Hyzaar (losartan potassium-hydrochlorothiazide) Tablets (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Rifampin Fluconazole Erythromycin Geriatric Use ADVERSE REACTIONS Postmarketing Experience Respiratory Dry cough

Lupron Depot 7.5 mg (leuprolide acetate for depot suspension) Please contact TAP Pharmaceuticals at 1-800-622-2011 for prescribing information.	PRECAUTIONS Geriatric Use

Lupron Depot - 3 Month 22.5 mg (leuprolide acetate for depot suspension) Please contact TAP Pharmaceuticals at 1-800-622-2011 for prescribing information.	PRECAUTIONS Geriatric Use ADVERSE REACTIONS Postmarketing Cardiovascular System Hypotension Pulmonary Embolism Changes in Bone Density

Lupron Depot - 4 Month 30 mg (leuprolide acetate for depot suspension) Please contact TAP Pharmaceuticals at 1-800-622-2011 for prescribing information.	PRECAUTIONS Geriatric Use ADVERSE REACTIONS Postmarketing Cardiovascular System Pulmonary Embolism

Meridia (sibutramine hydrochloride monohydrate) Capsules Please contact Abbott Laboratories at 1-800-255-5162 for prescribing information.	PRECAUTIONS Bleeding ADVERSE REACTIONS Psychiatric Hypersensitivity Other Adverse Events Postmarketing Reports, Other Urinary Retention PATIENT PACKAGE INSERT Who should not take Meridia? What medical conditions or information should I tell my doctor?

Norvir (ritonavir) Soft Gelatin Capsules and Oral Solution (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Table 5 Ergot Derivatives Table 6 Warfarin Table 7 Itraconazole Fluticasone ADVERSE REACTIONS Postmarketing Experience Body as a Whole Cardiovascular System Endocrine System Hemic and Lymphatic System Nervous System PATIENT PACKAGE INSERT Medicines that may require dosage adjustments Viagra

Plavix (clopidogrel bisulfate) Tablets Please contact Sanofi-Synthelabo at 1-212-551-4000 for prescribing information.	PRECAUTIONS General Use in Renally Impaired Patients Drug Interactions Warfarin ADVERSE REACTIONS Postmarketing Experience Body as a Whole Central and Peripheral Nervous System Disorders Collagen Disorders Gastrointestinal Disorders Liver and Biliary System Disorders Platelet, Bleeding and Clotting Disorders Respiratory System Disorders Skin and Appendage Disorders Urinary System Disorders

Pravachol (pravastatin sodium) Tablets (click product name to read prescribing information)	PRECAUTIONS Pediatric Use

Proscar (finasteride) Tablets (click product name to read prescribing information)	PRECAUTIONS Information for Patients ADVERSE REACTIONS Long-Term Treatment PATIENT PACKAGE INSERT What you need to know while taking Proscar

Pulmicort Respules (budesnonide inhalation suspension) (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Coadministration of Long-Term Ketoconazole and other known CYP3A4 Inhibitors

Pulmicort Turbuhaler (budesonide inhalation powder) (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Coadministration of Long-Term Ketoconazole and other known CYP3A4 Inhibitors

Reminyl (galantamine hydrobromide) Tablets and Oral Solution (click product name to read prescribing information)	PRECAUTIONS Information for Patients and Caregivers ADVERSE REACTIONS Postmarketing Experience Body as a Whole - General Disorders Central & Peripheral Nervous System Disorders Gastrointestinal System Disorders Metabolic & Nutritional Disorders

Rhinocort Aqua (budesonide) Nasal Spray (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Coadministration of Long-Term Ketoconazole and other known CYP3A4 Inhibitors

Sinequan (doxepin hydrochloride) Capsules and Oral Concentrate (click product name to read prescribing information)	PRECAUTIONS Drug Interactions

Symmetrel (amantadine hydrochloride) Tablets and Syrup (click product name to read prescribing information)	PRECAUTIONS Drug Interactions Quinine Impairment of Fertility Pregnancy Category C

Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate (click product name to read prescribing information)	PRECAUTIONS Pediatric Use ADVERSE REACTIONS Other Adverse Events in Pediatric Patients

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Brand (Generic) Name	Sections Modified
Azmacort (triamcinolone acetonide) Inhalation Aerosol (click product name to read prescribing information)	ADVERSE REACTIONS Postmarketing Experience

Glucotrol XL (glipizide) Extended Release Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Postmarketing Abdominal Pain

Trental (pentoxifylline) Tablets (click product name to read prescribing information)	ADVERSE REACTIONS Postmarketing Nervous Aseptic Meningitis

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